BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELT CLIP

    MDR report key: 4201129 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-42179
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP'S SCREEN WAS CRACKED. CUSTOMER STATED THAT THIS DAMAGE OCCURRED AS A RESULT OF THE INULIN PUMP HITTING THE GROUND. CUSTOMER REPORTED THAT THE INSULIN PUMP'S DISPLAY WAS SCRAMBLED AND COULD NOT BE READ. BLOOD GLUCOSE LEVEL WAS 178 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681541 BELT CLIP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-640

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR